Impact of Head of Bed Elevation in Symptoms of Patients With Gastroesophageal Reflux Disease

NCT02706938 | Completed Results

• 1 other identifier: IBELGA
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

BACKGROUND: Gastroesophageal reflux disease is a very frequent clinical condition and nocturnal symptoms are a cause of quality of life impairment, poor sleep quality and absenteeism. Head of bed elevation, as a low-cost non pharmacologic anti-reflux treatment is nowadays recommended, but its clinical impact in patients with nocturnal symptoms remains unknown due to inconsistent results and methodological limitations among different clinical trials, most of which were performed before the widespread use of proton pump inhibitors in clinical practice. HYPOTHESIS: Head of bed elevation is a useful treatment for patients with gastroesophageal reflux disease and nocturnal symptoms, and has a positive impact in quality of life in these patients. STUDY OBJECTIVE: To assess the effectiveness of head of bed elevation for treatment of patients with gastroesophageal reflux disease and nocturnal symptoms, and to determine the impact of this intervention in quality of life of these patients. METHODS: Randomized single-blind single-centre controlled clinical trial with a 2x2 cross-over design. A sample of 42 patients attending to the outpatient gastroenterology unit at Clínica Fundadores in Bogotá city, who met the inclusion criteria and had no exclusion criteria were selected to participate. Included patients were randomized to raise the head of bed with standard 20 cm-height wooden blocks or to sleep without bed inclination during the first 6 week period. After a 2 week washout period, allocation was crossed and participants were followed again during a second 6 week period. During the trial, every patient received standard pharmacological treatment with a proton pump inhibitor and/or sodium alginate. After allocation concealment, the researchers in charge of statistical analysis and reporting results were blinded for the non pharmacological intervention under study. Primary outcome was a significant symptom change according to Reflux Disease Questionnaire (RDQ) validated form. Secondary outcomes include impact on quality of life according to Short Form 36 (SF-36) validated questionnaire, patient preference and adverse events of non-pharmacological intervention. Statistical analysis was carried out with STATA 13.0 (Special Edition) for Windows. Differences with a p\<0,05 were accepted as statistically significant.

Conditions

Gastroesophageal Reflux Disease

Keywords

Gastroesophageal reflux disease; Head of bed elevation; Quality of life; Nocturnal symptoms; Lifestyle measures

Outcome Measures

Primary Outcomes (1)

• Change in Reflux Disease Questionnaire Scores Administered at Baseline and 6 Weeks After Each Intervention

  Change in Reflux Disease Questionnaire Scores administered at baseline and 6 weeks after each intervention. Range from 0 to 6, with a higher punctuation meaning a worse outcome. Symptom change of ≥ 0,6 points from baseline was considered clinically relevant.

  Primary outcome will be assessed at baseline and 6 weeks after starting each period

Secondary Outcomes (2)

• Change in Quality of Life as Assessed by Short Form 36 Questionnaire, Administered at Baseline and 6 Weeks After Each Intervention

  Secondary outcome will be assessed at baseline and 6 weeks after starting each period

• Patient Preference

  Secondary outcome will be assessed 14 weeks after starting the trial

Study Arms (2)

Head of bed elevation - Control

OTHER

Participants will sleep with head of bed raised with standard 20 cm-height wooden blocks during a first period of 6 weeks. After a washout 2 week period, participants will sleep in a bed without inclination for a second period of 6 weeks. During the trial, every patient will receive standard pharmacological treatment with a proton pump inhibitor and/or sodium alginate, according to clinical judgement.

Other: Head of bed elevation; Other: Standard treatment

Control - Head of bed elevation

OTHER

Participants will sleep in a bed without inclination during a first period of 6 weeks. After a washout 2 week period, participants will sleep with head of bed raised with standard 20 cm-height wooden blocks for a second period of 6 weeks. During the trial, every patient will receive standard pharmacological treatment with a proton pump inhibitor and/or sodium alginate, according to clinical judgement.

Other: Head of bed elevation; Other: Standard treatment

Interventions

Head of bed elevation OTHER

Head of bed elevation will be achieved with a pair of prisms of withered pine tree wood with dimensions (Height x Width x Depth) 20x18x18 cm. Each prism lying on the floor will support one of the head legs of the bed

Control - Head of bed elevation; Head of bed elevation - Control

Standard treatment OTHER

Standard pharmacological treatment with a proton pump inhibitor and/or sodium alginate, according to clinical judgement.

Control - Head of bed elevation; Head of bed elevation - Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Esophageal erosions
• Retrosternal pyrosis lasting ≥ 3 months
• Pyrosis and/or regurgitation with a frequency ≥ 3 nights per week
• GERD-associated sleep disturbance (insomnia, poor sleep quality) lasting ≥ 1 month
• GERD-associated sleep disturbance (insomnia, poor sleep quality) with a frequency ≥ 3 nights per week

You may not qualify if:

• Non-erosive gastroesophageal reflux disease (NERD)
• Peptic ulcer
• History of upper gastrointestinal surgery (except for cholecystectomy)
• Lactating or pregnant women
• Nighttime shift workers (12 am to 6 am)
• Obstructive sleep apnea hypopnea syndrome
• Chronic obstructive pulmonary disease
• Patients with nocturnal supplementary oxygen requirement
• Orthopnea
• Restless legs syndrome
• Patients consuming more than 3 cups of coffee per day
• Patients planning to travel beyond 3 time zones during study
• Patients being treated with sleep medication (e.g. anxiolytics, antihistamines, benzodiazepines) for less than 3 months
• Patients being treated with sleep medication (e.g. anxiolytics, antihistamines, benzodiazepines), when suspension or dose modification of this drugs is being planned during the study course

Sponsors & Collaborators

• Universidad Nacional de Colombia: lead

Study Sites (1)

Clínica Fundadores

Bogotá, Cundinamarca, Colombia

Location

Related Publications (27)

• Vakil N, van Zanten SV, Kahrilas P, Dent J, Jones R; Global Consensus Group. The Montreal definition and classification of gastroesophageal reflux disease: a global evidence-based consensus. Am J Gastroenterol. 2006 Aug;101(8):1900-20; quiz 1943. doi: 10.1111/j.1572-0241.2006.00630.x.

  PMID: 16928254 BACKGROUND

• Vakil N, Malfertheiner P, Salis G, Flook N, Hongo M. An international primary care survey of GERD terminology and guidelines. Dig Dis. 2008;26(3):231-6. doi: 10.1159/000121352. Epub 2008 May 6.

  PMID: 18463441 BACKGROUND

• Salis G. [Systematic review: Epidemiology of gastroesophageal reflux disease in Latin America]. Acta Gastroenterol Latinoam. 2011 Mar;41(1):60-9. Spanish.

  PMID: 21539070 BACKGROUND

• Farup C, Kleinman L, Sloan S, Ganoczy D, Chee E, Lee C, Revicki D. The impact of nocturnal symptoms associated with gastroesophageal reflux disease on health-related quality of life. Arch Intern Med. 2001 Jan 8;161(1):45-52. doi: 10.1001/archinte.161.1.45.

  PMID: 11146697 BACKGROUND

• Dean BB, Crawley JA, Schmitt CM, Wong J, Ofman JJ. The burden of illness of gastro-oesophageal reflux disease: impact on work productivity. Aliment Pharmacol Ther. 2003 May 15;17(10):1309-17. doi: 10.1046/j.1365-2036.2003.01588.x.

  PMID: 12755844 BACKGROUND

• Gross M, Beckenbauer U, Burkowitz J, Walther H, Brueggenjuergen B. Impact of gastro-oesophageal reflux disease on work productivity despite therapy with proton pump inhibitors in Germany. Eur J Med Res. 2010 Mar 30;15(3):124-30. doi: 10.1186/2047-783x-15-3-124.

  PMID: 20452898 BACKGROUND

• Orr WC, Heading R, Johnson LF, Kryger M. Review article: sleep and its relationship to gastro-oesophageal reflux. Aliment Pharmacol Ther. 2004 Dec;20 Suppl 9:39-46. doi: 10.1111/j.1365-2036.2004.02239.x.

  PMID: 15527463 BACKGROUND

• Orr WC, Allen ML, Robinson M. The pattern of nocturnal and diurnal esophageal acid exposure in the pathogenesis of erosive mucosal damage. Am J Gastroenterol. 1994 Apr;89(4):509-12.

  PMID: 8147351 BACKGROUND

• Adachi K, Fujishiro H, Katsube T, Yuki M, Ono M, Kawamura A, Rumi MA, Watanabe M, Kinoshita Y. Predominant nocturnal acid reflux in patients with Los Angeles grade C and D reflux esophagitis. J Gastroenterol Hepatol. 2001 Nov;16(11):1191-6. doi: 10.1046/j.1440-1746.2001.02617.x.

  PMID: 11903734 BACKGROUND

• Lopez-Alvarenga JC, Orr W, Vargas-Romero JA, Remes-Troche JM, Morales-Arambula M, Soto-Perez JC, Mateos-Perez G, Sobrino-Cossio S, Teramoto-Matsubara O, Lopez-Colombo A, Orozco-Gamiz A, Saez-Rios A, Arellano-Plancarte A, Chiu-Ugalde J, Tholen A, Horbach S, Lundberg L, Fass R. Relief of Night-time Symptoms Associated With Gastroesophageal Reflux Disease Following 4 Weeks of Treatment With Pantoprazole Magnesium: The Mexican Gastroesophageal Reflux Disease Working Group. J Neurogastroenterol Motil. 2014 Jan;20(1):64-73. doi: 10.5056/jnm.2014.20.1.64. Epub 2013 Dec 30.

  PMID: 24466446 BACKGROUND

• Gislason T, Janson C, Vermeire P, Plaschke P, Bjornsson E, Gislason D, Boman G. Respiratory symptoms and nocturnal gastroesophageal reflux: a population-based study of young adults in three European countries. Chest. 2002 Jan;121(1):158-63. doi: 10.1378/chest.121.1.158.

  PMID: 11796445 BACKGROUND

• Katz PO, Gerson LB, Vela MF. Guidelines for the diagnosis and management of gastroesophageal reflux disease. Am J Gastroenterol. 2013 Mar;108(3):308-28; quiz 329. doi: 10.1038/ajg.2012.444. Epub 2013 Feb 19. No abstract available.

  PMID: 23419381 BACKGROUND

• Federacao Brasileira de Gastroenterologia; Sociedade Brasileira de Endoscopia Digestiva; Colegio Brasileiro de Cirurgia Digestiva; Sociedade Brasileira de Pneumologia; Associacao Brasileira de Otorrinolaringologia; Cirurgia Cervico-Facial. [Gastroesophageal reflux disease: non-pharmacological treatment]. Rev Assoc Med Bras (1992). 2012 Jan-Feb;58(1):18-24; quiz 25. doi: 10.1590/s0104-42302012000100009. No abstract available. Portuguese.

  PMID: 22392311 BACKGROUND

• Dyspepsia and Gastro-Oesophageal Reflux Disease: Investigation and Management of Dyspepsia, Symptoms Suggestive of Gastro-Oesophageal Reflux Disease, or Both. London: National Institute for Health and Care Excellence (NICE); 2014 Sep. Available from http://www.ncbi.nlm.nih.gov/books/NBK248065/

  PMID: 25340236 BACKGROUND

• Gastroenterological Society of Australia (GESA). Reflux disease: Gastrooesophageal reflux disease in adults. Victoria: GESA 2011. Available from: http://www.gesa.org.au/files/editor_upload/File/Professional/Reflux_Disease.pdf (Accessed Dic, 2014).

  BACKGROUND

• Stanciu C, Bennett JR. Effects of posture on gastro-oesophageal reflux. Digestion. 1977 Feb;15(2):104-9. doi: 10.1159/000197991.

  PMID: 14044 BACKGROUND

• Johnson LF, DeMeester TR. Evaluation of elevation of the head of the bed, bethanechol, and antacid form tablets on gastroesophageal reflux. Dig Dis Sci. 1981 Aug;26(8):673-80. doi: 10.1007/BF01316854.

  PMID: 7261830 BACKGROUND

• Khan BA, Sodhi JS, Zargar SA, Javid G, Yattoo GN, Shah A, Gulzar GM, Khan MA. Effect of bed head elevation during sleep in symptomatic patients of nocturnal gastroesophageal reflux. J Gastroenterol Hepatol. 2012 Jun;27(6):1078-82. doi: 10.1111/j.1440-1746.2011.06968.x.

  PMID: 22098332 BACKGROUND

• Hamilton JW, Boisen RJ, Yamamoto DT, Wagner JL, Reichelderfer M. Sleeping on a wedge diminishes exposure of the esophagus to refluxed acid. Dig Dis Sci. 1988 May;33(5):518-22. doi: 10.1007/BF01798350.

  PMID: 3359906 BACKGROUND

• Harvey RF, Gordon PC, Hadley N, Long DE, Gill TR, Macpherson RI, Beats BC, Tottle AJ. Effects of sleeping with the bed-head raised and of ranitidine in patients with severe peptic oesophagitis. Lancet. 1987 Nov 21;2(8569):1200-3. doi: 10.1016/s0140-6736(87)91332-8.

  PMID: 2890820 BACKGROUND

• Pollmann H, Zillessen E, Pohl J, Rosemeyer D, Abucar A, Armbrecht U, Bornhofen B, Herz R. [Effect of elevated head position in bed in therapy of gastroesophageal reflux]. Z Gastroenterol. 1996 Jun;34 Suppl 2:93-9. German.

  PMID: 8767437 BACKGROUND

• Kaltenbach T, Crockett S, Gerson LB. Are lifestyle measures effective in patients with gastroesophageal reflux disease? An evidence-based approach. Arch Intern Med. 2006 May 8;166(9):965-71. doi: 10.1001/archinte.166.9.965.

  PMID: 16682569 BACKGROUND

• Gerson LB, Fass R. A systematic review of the definitions, prevalence, and response to treatment of nocturnal gastroesophageal reflux disease. Clin Gastroenterol Hepatol. 2009 Apr;7(4):372-8; quiz 367. doi: 10.1016/j.cgh.2008.11.021. Epub 2008 Dec 3.

  PMID: 19111949 BACKGROUND

• Nuevo J, Tafalla M, Zapardiel J. [Validation of the Reflux Disease Questionnaire (RDQ) and Gastrointestinal Impact Scale (GIS) in patients with gastroesophageal reflux disease in the Spanish population]. Gastroenterol Hepatol. 2009 Apr;32(4):264-73. doi: 10.1016/j.gastrohep.2008.12.004. Epub 2009 Apr 16. Spanish.

  PMID: 19371971 BACKGROUND

• Rossetti G, Limongelli P, Cimmino M, Napoletano D, Bondanese MC, Romano G, Pratilas M, Guerriero L, Orlando F, Conzo G, Amato B, Docimo G, Tolone S, Brusciano L, Docimo L, Fei L. Outcome of medical and surgical therapy of GERD: predictive role of quality of life scores and instrumental evaluation. Int J Surg. 2014;12 Suppl 1:S112-6. doi: 10.1016/j.ijsu.2014.05.034. Epub 2014 Jun 2.

  PMID: 24946311 BACKGROUND

• Uniform requirements for manuscripts submitted to biomedical journals: Writing and editing for biomedical publication. J Pharmacol Pharmacother. 2010 Jan;1(1):42-58. No abstract available.

  PMID: 21808590 BACKGROUND

• Villamil Morales IM, Gallego Ospina DM, Otero Regino WA. Impact of head of bed elevation in symptoms of patients with gastroesophageal reflux disease: a randomized single-blind study (IBELGA). Gastroenterol Hepatol. 2020 Jun-Jul;43(6):310-321. doi: 10.1016/j.gastrohep.2020.01.007. Epub 2020 Mar 27. English, Spanish.

  PMID: 32229033 DERIVED

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Results Point of Contact

• Title: Dr. Ivan Mauricio Villamil Morales
• Organization: Universidad Nacional de Colombia

imvillamilm@unal.edu.co

+573178755369

Study Officials

• Ivan M Villamil Morales, MD

  Universidad Nacional de Colombia

  PRINCIPAL INVESTIGATOR

• William A Otero Regino, MD, MSc

  Universidad Nacional de Colombia, Clínica Fundadores

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Because HBE is not susceptible to double-blinding, patients allocated to the intervention group will always be aware of the group they belong to. However, the researcher in charge of statistical analysis of data and writing the results report will work with random-generated alphabetical group codes for masking the intervention in each one of the periods of the trial.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized single-blind single-centre controlled clinical trial with a 2x2 cross-over design.

Study Record Dates

• First Submitted: March 8, 2016
• First Posted: March 11, 2016
• Study Start: April 8, 2016
• Primary Completion: November 15, 2017
• Study Completion: November 15, 2017
• Last Updated: June 24, 2019
• Results First Posted: June 24, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)